FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C-MAX+ (PLUS)
K Number: K130864
·
Decision Feb 6, 2014
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
35
Applicant Total
3
Review Days
315
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Basic Information
- Device Name
- C-MAX+ (PLUS)
- K Number
- K130864
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5150
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aat Alber Antriebstechnik GmbH
- Date Received
- March 28, 2013
- Decision Date
- February 6, 2014
- Product Code
- ILK
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ILK | Transport, Patient, Powered | FDA class 2 | Physical Medicine |
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